Mumbai, Dec 20: The Rs 541- crore Cipla has filed international patents for an omeprazole formulation even as it is working on a host of sophisticated ``molecular manipulation'' techniques (like chiral synthesis), to take on the challenges of the impending product patents regime.The Mumbai-based company also plans to carve a niche for itself in ``allovedic'' therapy, which basically applies the standards of allopathy to ayurvedic medicines.Cipla chairman and managing director, YK Hamied, told The Financial Express that the company's multi-pronged strategy would see it emerge as an international generics player even as it works at a frenzied pace to zero in on chiral drugs for salbutamol, methylphenidate, corticosteroids etc.
Hamied said that the company had filed for patents in the US, Europe, Australia and South Africa for its omeprazole and cyclosporin formulations besides synthesis of guggalsterone. These patents, if approved, will open up a billion dollar global market for Cipla in omeprazole(currently estimated at $ 4 billion) when the bulk drug goes off patent next year.
The omeprazole formulation patent which expires in 2005, is held by Swedish giant Astra.
Cipla director Amar Lulla said that the company's omeprazole formulation equals the orginator's drug in terms of efficacy even as it has other novel properties. This version does not have a ``seal coat,'' it is learnt.On chiral drugs for the next millenium, Cipla is already working in tandem with KK Midha, Research director of the Drug Metabolism, Drug Disposition Research Unit, University of Saskatchewan, Canada for methylphenidate. Dl-threo Methylphenidate (MPH), in which d-threo MPH is more active than the I-antipode, is widely prescribed to treat children with attention deficit hyperactivity disorder.
Chiral drugs are essentially based on the principle that most substances comprise two, nearly identical ``mirror image'' molecules, called isomers. Often one isomer of a drug contributes to the most useful activity while the othercauses most of the side effects. Hamied expects chiral drugs to account for 25 per cent of all leading medicines after 2000.
Chief of research at Inquire, Nishid Shah, says, ``Cipla's success in R&D is a matter of national pride and shows the way for the pharma industry. Companies using similar chiral technologies like Sepracor enjoy a market capitalisation of over $2.6 billion. We expect the true potential of Cipla to be realised over the next two to three years.''
Analysts say that Cipla's potential strength in chiral synthesis could open up a new window of opportunity for the company. ``If Cipla could extend this gameplan to the international market, essentially repacking a successful drug by leaving out unnecessary components, the potential is immense. Eli Lilly recently agreed to pay Sepracor, a small Massachusetts-based company, up to $90 million for jointly developing an improved version of the $3 billion block-buster Prozac brand (for treatment of depression),'' they said.On the formulationsfront, Lulla added that Cipla would also work on novel delivery systems. Besides, the company had acquired new chemical entities like a candonium iodide injection from the CSIR on a non-exclusive basis and was keen on similar partnerships for the development of technology.
Analysts said that Cipla's well-defined R&D strategy adds a new dimension to the company's existing strengths in developing novel process for products like carvedilol (an alpha/beta blocker), ebastine (an antihistamine) and sildenafil citrate (for erectile dysfunction).
For the year ended 1997-98, the company invested four per cent of its sales turnover (roughly Rs 21 crore) in research and development.
Copyright © 1998 Indian Express Newspapers (Bombay) Ltd.